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OpenTrials
Completed

NCT Number: NCT03031457

Microsurgical Breast Reconstruction & VTE

Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery. Significant morbidity and mortality is associated with VTE events. This disease entity represents the most common cause of preventable in-hospital death as evidenced by over 100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial, with annual costs to the U.S. healthcare system in excess of $7 billion.

Cancer patients have been identified as a particularly vulnerable patient population. Of these, breast cancer patients represent the largest group treated by plastic surgeons. An increasing number of breast reconstructions are performed in the U.S. with a documented 35% increase in the annual number of breast reconstructions since 2000. Over 106,000 breast reconstructions were performed in 2015 alone.

Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is associated with the highest risk for VTE. We believe that a key element rendering these patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is supported by the observation that VTE risk remains elevated for up to 12 weeks postoperatively. We hypothesize that lower extremity deep venous system stasis is a procedure-specific key contributing factor to postoperative VTE risk.

This study examines the duration of postoperative lower extremity venous stasis to identify patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging technology to examine the lower extremity deep venous system preoperatively, on postoperative day 1, and on the day of discharge to determine if patients display radiographic evidence of lower extremity venous stasis at the time of hospital discharge.

A better understanding of pathophysiologic mechanisms that contribute to the development of VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE prophylaxis, thus, favorably impacting clinical outcome in a large patient population.

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Stanford University Medical Center

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • see study population description

Exclusion criteria

  • Superficial inferior epigastric artery flaps
  • Donor-sites other than the abdomen
  • Chronic obstructive pulmonary disease (COPD)
  • Liver disease.

Treatment and study plan

Duplex ultrasound

Diagnostic Test

Duplex ultrasound of lower extremity venous system

Primary outcomes

  1. Vessel diameter (in cm)

    Time frame: 1 Day of discharge

  2. Cross-sectional area (in cm^2)

    Time frame: 1 Day of discharge

  3. Flow velocity (in cm/sec)

    Time frame: 1 Day of discharge

Secondary outcomes

  1. 90-day VTE event

    Time frame: 90-day

  2. Abdominal hernia/bulge rate at 1 year postop

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • University of Utah

Registry information

Official study title

Microsurgical Breast Reconstruction - Identifying Procedure-Specific Risk Factors for Venous Thromboembolism

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2017
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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